FLOVENT
- Product NDC
- 50090-0916
- 11-digit product format
- 500900916
- Labeler code
- 50090
- Product ID
- 50090-0916_3c3ea164-3f7a-43d3-9375-8486e46d16aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluticasone propionate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- A-S Medication Solutions
- Application
- NDA021433
- Marketing category
- NDA
- Marketing start
- 2007-04-06
- Marketing end
- 0000-00-00
- Substance
- FLUTICASONE PROPIONATE
- Active strength
- 44 ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 50090-0916 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 50090-0916 | 50090-0916-0 | D | Discontinued by firm | 2026-08-10 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021433-001 | FLOVENT HFA | FLUTICASONE PROPIONATE | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | |
| N021433-002 | FLOVENT HFA | FLUTICASONE PROPIONATE | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | |
| N021433-003 | FLOVENT HFA | FLUTICASONE PROPIONATE | 0.044MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2004-05-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021433-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021433-003 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0916-0 | GM - Gram | 50090-0916 | a20e4b29-0589-45f1-a09a-6247320eac34 | 1 | 2018-10-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-0916 | FLOVENT HFA (FLUTICASONE PROPIONATE) AEROSOL, METERED [A-S MEDICATION SOLUTIONS] | 17 | Legacy NDC | 20231210_ac03cfeb-b99d-4e1d-ae80-fc2cef33a945.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fluticasone Propionate HFA | FLUTICASONE PROPIONATE | Preferred Pharmaceuticals Inc. | ff1cf174-ae6f-45f0-a081-26a34e55f9ea | 2026-01-20 | Warnings, Adverse reactions | 021433 NDA021433 |
| Fluticasone Propionate HFA | FLUTICASONE PROPIONATE | A-S Medication Solutions | faaa1436-dafb-4f65-b062-b51b902f43c5 | 2024-10-29 | Warnings, Adverse reactions | 021433 NDA021433 |
| Fluticasone Propionate HFA | FLUTICASONE PROPIONATE | A-S Medication Solutions | 674b1c81-359d-4fc4-8ce6-a53931b171e0 | 2024-01-02 | Warnings, Adverse reactions | 021433 NDA021433 |
| FLOVENT HFA | FLUTICASONE PROPIONATE | A-S Medication Solutions | 74563f7b-8512-4b76-8c55-b88b9cd3206b | 2023-12-09 | Warnings, Adverse reactions | 021433 NDA021433 |
| Fluticasone Propionate HFA | FLUTICASONE PROPIONATE | A-S Medication Solutions | 4d3e6801-5fbf-4cf6-b3d8-35fe276b8b6d | 2023-11-17 | Warnings, Adverse reactions | 021433 NDA021433 |
| Fluticasone Propionate HFA | FLUTICASONE PROPIONATE | Prasco Laboratories | 99249b31-bf0a-464f-8335-845279350dbe | 2023-09-28 | Warnings, Adverse reactions | 021433 NDA021433 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-0916-0 | 50090091600 | 1 INHALER in 1 CARTON (50090-0916-0) > 120 AEROSOL, METERED in 1 INHALER | 1 inhaler | 2014-11-28 | 0000-00-00 | No | No | Current |